Device Classification Name |
coagulator-cutter, endoscopic, unipolar (and accessories)
|
510(k) Number |
K010425 |
Device Name |
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) |
Applicant |
HDC CORP. |
2109 O'TOOLE AVE. |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
EARL SMART |
Correspondent |
HDC CORP. |
2109 O'TOOLE AVE. |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
EARL SMART |
Regulation Number | 884.4160
|
Classification Product Code |
|
Date Received | 02/13/2001 |
Decision Date | 03/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|